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FDA 510(k)

Lymphedema Compression

K-Number: K240011 · 2024-02-23

ApplicantJkh Health Co., Ltd.
Decision Date2024-02-23
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lymphedema Compression is a medical device manufactured by Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2024-02-23 under approval number K240011. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lymphedema Compression?

Lymphedema Compression is a medical device that received FDA 510(k) clearance on 2024-02-23. It is manufactured by Jkh Health Co., Ltd.. The 510(k) number is K240011.

When was Lymphedema Compression approved by the FDA?

Lymphedema Compression received FDA 510(k) clearance on 2024-02-23, under approval number K240011.

What company makes Lymphedema Compression?

Lymphedema Compression is manufactured by Jkh Health Co., Ltd..

What is the FDA product code for Lymphedema Compression?

The FDA product code for Lymphedema Compression is JOW.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07187726 Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk RECRUITING NCT05326165 Early Intervention NOT_YET_RECRUITING NCT06418282 Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema RECRUITING NCT07549594 Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy. NOT_YET_RECRUITING

Other Devices by Jkh Health Co., Ltd.

K153520Electronic Pulse Stimulator K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 K200561StimPlus Patch, StimPlus Patch, StimPlus Patch K202839Overlapped Compression Therapy K211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 K223541Cold/Hot Compression

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Related Devices (Code: JOW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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